Clinical Development Strategy

Documenting clinical and scientific benchmarks of product performance and supporting data for competitors and recent product filings in the related area(s);

Identifying new or proposed regulatory guidelines or rulings that will impact expectations for future trials;

Identifying the key users and/or prescribers of the product and understanding how they will evaluate the new product, including the level of performance along several dimensions such as safety, efficacy, ease of use, etc., that will be required to move them to change current practices;

Evaluating various trial design options and prioritizing the options by comparing the likely duration and cost of each, as well as the probability of success given available product and market information and the likelihood that the results, if successful, will be sufficient to gain adoption and to what degree penetration is likely to occur with various claims possibilities.